Kidney Precision Medicine Project Recruitment Sites (U01 Clinical Trial Not Allowed) | RFA DK 20 026

Kidney Precision Medicine Project (KPMP) Recruitment Sites (RFA DK 20 026) - FAQs

1) What is this funding opportunity?

This opportunity supports Kidney Precision Medicine Project (KPMP) Recruitment Sites under NIH FOA RFA DK 20 026. It is an NIH cooperative agreement (activity code U01) and is designated as "clinical trial not allowed."

2) What is the main purpose of KPMP Recruitment Sites?

The purpose is to support clinical centers that can find, enroll, and follow participants with acute kidney injury (AKI) and/or chronic kidney disease (CKD) in a longitudinal cohort study, while generating high-quality human kidney tissue samples linked to deep clinical data to help researchers understand kidney disease mechanisms directly in affected human tissue.

3) What are Recruitment Sites expected to do?

Recruitment Sites are expected to:

• Identify, enroll, and follow participants with AKI and/or CKD in a longitudinal cohort study.
• Carry out standardized, protocol-based research kidney biopsies.
• Manage clinical and operational workflows related to biospecimen collection.
• Collect, coordinate handling, and perform initial evaluation of biopsy material.
• Ensure biospecimen collection and associated workflows are consistent across the national KPMP network.

4) Why are standardized, protocol-based research kidney biopsies emphasized?

A central expectation is that Recruitment Sites can perform research kidney biopsies under a common protocol and manage biospecimen workflows in a consistent way across the national network. This consistency supports reliable integration of tissue and data into the broader KPMP Kidney Tissue Atlas effort.

5) Are Recruitment Sites working independently or as part of a consortium?

Recruitment Sites are designed to function as part of an integrated consortium, not in isolation. They work alongside Tissue Interrogation Sites (TIS), the Kidney Tissue Atlas Coordinating Center (KTACC), and a Central Hub (CH).

6) What happens to biopsy samples after a Recruitment Site collects them?

Recruitment Sites collect and coordinate the handling and initial evaluation of biopsy material, then work closely with other consortium components to ensure samples and associated metadata are processed, analyzed, and integrated into a broader Kidney Tissue Atlas.

7) What is the long-term scientific goal of the overall KPMP consortium?

The long-term goal is to build a Kidney Tissue Atlas that maps kidney cell types and states, interstitial and structural components, and molecular pathways involved in AKI and CKD. The atlas is intended to help define biologically meaningful disease subgroups and highlight potential therapeutic targets for future treatment development.

8) What patient populations are the focus of recruitment?

The focus is on participants with acute kidney injury (AKI) and/or chronic kidney disease (CKD) who will be enrolled and followed in a longitudinal cohort study.

9) What type of NIH award mechanism is used?

The mechanism is a cooperative agreement (U01). Cooperative agreements typically involve substantial programmatic involvement by NIH staff compared to standard research project grants.

10) Does this FOA allow clinical trials?

No. The FOA is identified as "clinical trial not allowed."

11) What kinds of organizations are eligible to apply?

Eligibility is broad and includes many U.S.-based organization types, including:

• State, county, city, and special district governments
• Independent school districts
• Public and state-controlled institutions of higher education
• Private institutions of higher education
• Federally recognized Native American tribal governments
• Tribal organizations and tribal governments that are not federally recognized
• Public housing authorities/Indian housing authorities
• Nonprofits (with or without 501(c)(3) status) that are not institutions of higher education
• For-profit organizations other than small businesses
• Small businesses
• Other organizations

12) Are any additional applicant categories explicitly noted as eligible?

Yes. The FOA explicitly notes additional eligible applicant categories including:

• Alaska Native and Native Hawaiian Serving Institutions
• AANAPISISs
• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Faith-based or community-based organizations
• Regional organizations
• Eligible federal agencies
• U.S. territories or possessions

13) Are non-U.S. organizations eligible to apply?

No. The FOA excludes non-U.S. entities from applying.

14) Can a U.S. organization apply if it has a non-U.S. component?

The FOA excludes non-U.S. components of U.S. organizations from applying. However, it allows foreign components as defined under the NIH Grants Policy Statement, meaning a U.S. applicant may include certain foreign activities as part of the project if they meet NIH policy requirements, even though a foreign institution cannot be the applicant organization.

15) What is meant by "cooperative agreement" in this context?

This is described as an NIH discretionary grant program using a cooperative agreement structure, which generally indicates NIH staff will have substantial programmatic involvement during the project, compared with a standard grant mechanism.

16) What is the CFDA number for this opportunity?

The CFDA number listed is 93.847.

17) When was this FOA created and when did it close?

The FOA was created on April 22, 2021, and the original closing date was September 23, 2021.

18) What is the general activity focus area?

The activity focus is health-related, with the listing also showing "Food and Nutrition, Health" as the activity category. The content is centered on kidney precision medicine infrastructure, including recruitment, protocol-based kidney biopsies, and contributing tissue and data into the national KPMP atlas system.

19) What does "deep clinical data" imply in the goals of this project?

Based on the description provided, the project aims to link high-quality human kidney tissue samples with rich clinical information collected in the longitudinal cohort so researchers can better understand disease mechanisms directly in human kidney tissue affected by AKI and CKD.

20) What makes a site a good fit for this Recruitment Site role?

Based on the stated expectations, a strong fit would be a clinical center that can reliably recruit and follow AKI/CKD participants, perform standardized research kidney biopsies under common protocols, and manage biospecimen collection workflows in a way that is consistent with the national KPMP network and compatible with consortium coordination and atlas integration.